AffyImmune receives FDA regenerative medicine advanced therapy (RMAT) designation for AIC100 in recurrent anaplastic thyroid cancer
- AffyImmune's AIC100 receives RMAT designation from the FDA for recurrent anaplastic thyroid cancer (ATC).
- RMAT designation aims to expedite the development and review of regenerative medicine therapies.
- The designation was based on safety and efficacy data from the first ten patients in a Phase 1 study.
- Interim results from the Phase 1 study showed a metabolic complete response in one patient with ATC.
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BioAtla granted FDA fast track designation for ozuriftamab vedotin for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck
- Ozuriftamab vedotin has shown promising clinical activity with a manageable safety profile in Phase 2 trials for treatment-refractory SCCHN patients.
- The FDA's Fast Track Designation aims to expedite the development and review process for drugs addressing serious conditions with unmet medical needs.
- BioAtla plans to meet with the FDA in the second half of 2024 to discuss a potential registrational trial.
- Ozuriftamab vedotin targets ROR2, a receptor tyrosine kinase associated with poor prognosis and resistance to therapies in various solid tumors.
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Anixa Biosciences announces FDA approval of individual patient IND for its ovarian cancer CAR-T therapy
- Anixa Biosciences and Moffitt Cancer Center received FDA approval for an individual patient IND for a second dose of CAR-T therapy.
- The approval follows encouraging findings of necrosis, inflammation, and T cell infiltration in a tumor biopsy of a patient in the lowest dose cohort.
- The Phase I clinical trial is treating recurrent ovarian cancer patients who have failed standard-of-care therapies.
- Dose escalation will continue after confirming the safety of previous dosages.
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Merus announces first patient dosed in phase 3 trial evaluating petosemtamab in head and neck cancer
- Merus has dosed the first patient in the phase 3 LiGeR-HN2 trial for petosemtamab.
- The trial compares petosemtamab to single-agent chemotherapy or cetuximab in 2/3L recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC).
- Primary endpoints include overall response rate and overall survival, with secondary endpoints being duration of response and progression-free survival.
- Approximately 500 patients will be enrolled in the trial.
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Kronos Bio doses first patient with KB-0742 in expansion cohort for platinum-resistant ovarian cancer
- First patient dosed with KB-0742 at 80mg on a four-days-on, three-days-off schedule.
- Expansion cohort focuses on platinum-resistant high-grade serous ovarian cancer (HGSOC).
- KB-0742 has shown preliminary anti-tumor activity and no grade 3 or 4 neutropenia in over 100 patients.
- Efficacy update expected in the first half of 2025.
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Hadassah Cancer Research Institute announces groundbreaking advance in personalized cancer care
- Hadassah Cancer Research Institute (HCRI) unveils MESiCA, a novel machine learning model for cancer diagnosis and treatment.
- MESiCA can detect dominant mutational signatures using only a small number of mutations, making it suitable for routine clinical use.
- Validated in over 60,000 cancer samples, MESiCA reveals crucial signatures linked to better survival rates and treatment responses.
- This breakthrough enables clinicians to prescribe more accurate personalized treatment plans, improving patient outcomes.
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FDA accepts Telix NDA for new prostate cancer imaging agent
- The FDA has accepted Telix Pharmaceuticals' NDA for TLX007-CDx, a new PSMA-PET imaging agent for prostate cancer.
- The PDUFA goal date is set for March 24, 2025.
- The new Kit aims to extend the geographic distribution radius of PSMA imaging products, enhancing patient access.
- If approved, TLX007-CDx will leverage Telix’s nuclear pharmacy distribution partnerships to reach underserved populations.
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Blue Earth Therapeutics announces clinical research collaboration with UCL to develop innovative alpha-labelled radioligand therapy for prostate cancer
- Blue Earth Therapeutics has signed a clinical research collaboration with University College London (UCL).
- The collaboration focuses on a Phase 1/2 trial to evaluate 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer.
- The trial will assess safety, tolerability, radiation dosimetry, and anti-tumor activity.
- The study will be conducted at the UCL Cancer Institute by the Treatment Resistance Group under Professor Gerhardt Attard.
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Pinetree Therapeutics announces exclusive option and global license agreement for preclinical EGFR degrader candidate with AstraZeneca
- Pinetree Therapeutics has entered into an exclusive option and global license agreement with AstraZeneca for a preclinical EGFR degrader candidate.
- Pinetree will receive up to $45 million in upfront and near-term payments, with the total deal value exceeding $500 million, including potential milestone payments.
- AstraZeneca will have the exclusive option to license the EGFR degrader for global development and commercialization.
- The candidate, developed from Pinetree's AbReptorâ„¢ platform, has shown promising preclinical anti-tumor activity in drug- and TKI-resistant tumors.
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BostonGene and Sylvester Comprehensive Cancer Center at the University of Miami collaborate to advance care for cancer patients
- BostonGene and Sylvester Comprehensive Cancer Center have announced a master agreement to advance collaborative research.
- The collaboration will focus on validating blood- and bone marrow-based assays for hematological cancers.
- The flagship study will evaluate the utility of bone marrow aspirates for clinical testing in multiple myeloma patients.
- Traditional diagnostic methods like FISH and cytogenetics will be compared with BostonGene's NGS-based tumor profiling to improve molecular subtyping.
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